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fda_recall · device_recall · critical

Baxter Healthcare Corporation — Class I recall: Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937.…

Event date
2026-04-08 00:00:00Z
Observed
2026-07-16 23:20:09Z
Source ID
Z-1637-2026
Payload hash
a88b570f266cde040d3cdb2c

Summary

Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that patients or caregivers may be unaware of a possible decrease in oxygen levels (oxygen desaturation), or potential lung tissue injury from overexpansion (barotrauma) when the Volara device is u… Status: Ongoing.

Frequently asked questions

Has Baxter Healthcare Corporation had other FDA enforcement actions?
Yes. Argus HQ has recorded 208 total FDA actions tied to Baxter Healthcare Corporation: 0 warning letters, 208 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?
This is an Argus HQ record of a FDA Recall, tagged critical severity by Argus HQ. FDA published the underlying record on 2026-04-08; Argus observed and indexed it on 2026-07-16.
Where can I verify this record directly with FDA?
The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA
Argus HQ Research (2026). Baxter Healthcare Corporation — Class I recall: Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937.…. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-baxter-healthcare-corporation-z-1637-2026
MLA
"Baxter Healthcare Corporation — Class I recall: Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937.…." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/events/fda-recall-baxter-healthcare-corporation-z-1637-2026.
Chicago
Argus HQ Research. "Baxter Healthcare Corporation — Class I recall: Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937.…." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-baxter-healthcare-corporation-z-1637-2026.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_baxter_healthcare_corporation_z_1637_2026_2026,
  title = {Baxter Healthcare Corporation — Class I recall: Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937.…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-baxter-healthcare-corporation-z-1637-2026},
  note = {Accessed: July 17, 2026}
}

Informational only. Not legal, financial, or medical advice.